Manufacturing Engineering Manager
iRhythm
 Cypress, CA

Job Post - Manufacturing Engineering Manager



About iRhythm:



iRhythm is a leading digital healthcare company focused on the way cardiac arrhythmias are clinically diagnosed by combining our wearable biosensing technology with powerful cloud-based data analytics and machine- learning capabilities. Our goal is to be the leading provider of first-line ambulatory ECG monitoring for patients at risk for arrhythmias. iRhythm’s continuous ambulatory monitoring has already put over 2 million patients and their doctors on a shorter path to what they both need – answers.



About this role:

iRhythm is currently seeking an experienced Manufacturing Engineering Manager in our Cypress, CA location. The role of the Manufacturing Engineering Manager is responsible for developing, implementing and improving all manufacturing processes for the site. This includes manufacturing transfer, equipment acquisition and implementation, sustaining engineering and V&V. Plan, direct and coordinate the work activities and resources necessary for developing and implementing manufacturing processes in accordance with quality, cost and quantity specifications.



Job Responsibilities Include:


  • Develops and maintains manufacturing processes, new products, product changes and enhancements, as well as related tooling and fixtures.

  • Support prototype and pilot production, facilities and planning, when appropriate.

  • Specify requirements and source automation equipment for scaling manufacturing

  • Interfaces with other departments to solve production problems.

  • Investigation and testing of product processes

  • Manages manufacturing efforts associated with new product transfer between R&D and manufacturing.

  • Drafts and executes validation of product, equipment and processes

  • Manages builds for new product development in prototype and pilot production setting, including training of operators and coordination with production planning as needed

  • Analyze data and improve processes to assure robust/repeatable manufacturing processes

  • Confers with appropriate departments, resources, and/or outside services to prepare process modifications, clarify problems and develop processes

  • Review and develop manufacturing documents

  • Provide solutions to complex problems including, but not limited to, those related to process, equipment, material, supply chain, documentation, equipment validation, IQ/OQ/PQ, PLM, and other applicable QMS / business processes.

  • Perform root cause analysis and implement process improvements to improve manufacturing yield.

  • Prepare and review manufacturing procedures, test protocols and reports, and other controlled documentation.

  • Support the design and development of tooling and fixtures to effectively manufacture new and existing products.

  • Searches and implements new technologies to improve manufacturing processes and equipment design

  • Demonstrated analytical skills with the ability to present data in meaningful and relevant fashion to aid in decision making process

  • Establish and maintain data monitoring for key processes, i.e., FYP’s, CPK’s etc.

  • Experience with risk-based failure mode analysis


About you:

 


  • Bachelor’s degree in Mechanical Engineering or alternate technical discipline.

  • Minimum 10+ years’ progressive manufacturing management experience.

  • Medical Device, Pharma, or Biotech experience; thorough understanding of ISO 13485 and FDA regulations.

FLSA Status: Exempt

As a part of our core values, we ensure a diverse and inclusive workforce. We welcome and celebrate people of all backgrounds, experiences, skills and perspectives. iRhythm Technologies, Inc. is an Equal Opportunity Employer (M/F/V/D). Pursuant to San Francisco Fair Chance Ordinance, we will consider for employment all qualified applicants with arrest and conviction records.

Make iRhythm your path forward.